Post Dural Puncture HeadacheNCT00809627
Caffeine Versus Placebo for Spinal Headaches
A study testing Caffeine and saline in people with Post Dural Puncture Headache, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache"). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Post Dural Puncture Headache
- What is being tested?
- Caffeine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed with post dural puncture headache
Who cannot join
- age < 18
- pregnant
- allergic to caffeine
- cardiac or peripheral vascular disease
- uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Emergency Department, Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Official title: A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department
Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache").
Read the detailed description
Pain will be assessed at set intervals using a Visual Analog Scale. Blood patch therapy will be offered to all those still in pain at the end of one hour after drug administration.
- Conditions
- Post Dural Puncture Headache
- Being tested
- Caffeine, saline
- Keywords
- headache, caffeine, pain
- Medical subject headings
- Post-Dural Puncture Headache, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Also called Treatment group
Caffeine 500 mg IV
salineDrug
Also called Placebo control group
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | IV caffeine with saline and opiate Receives: Drug: Caffeine |
| 2 | Placebo comparator | IV saline with opiate Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as measured by Visual Analog Scale
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Why it stopped: Study never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Dural Puncture HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mark A Kostic, MD, Study chair, United States Naval Medical Center, PortsmouthMarcelo Darabos, MD, Principal investigator, United States Naval Medical Center, Portsmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809627
- Sponsor's protocol ID
- CIP 2006 0051
- Status last verified
- Aug 2025
- First submitted
- 16 Dec 2008
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department
- ClinicalTrials.gov ID
- NCT00809627
- Acronym / sponsor ID
- CIP 2006 0051
- Conditions
- Post Dural Puncture Headache
- Keywords
- headache, caffeine, pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache").
Detailed description
Pain will be assessed at set intervals using a Visual Analog Scale. Blood patch therapy will be offered to all those still in pain at the end of one hour after drug administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CaffeineIV caffeine with saline and opiate |
| 2 | Placebo comparator | Drug: salineIV saline with opiate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diagnosed with post dural puncture headache
Key exclusion criteria (5 listed)
- age < 18
- pregnant
- allergic to caffeine
- cardiac or peripheral vascular disease
- uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineAlso: Treatment groupCaffeine 500 mg IV | Drug | 1 |
| salineAlso: Placebo control groupNormal saline | Drug | 2 |
Primary outcome
Pain as measured by Visual Analog Scale
Time frame: 60 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Kostic, MD study chair
United States Naval Medical Center, Portsmouth
Marcelo Darabos, MD principal investigator
United States Naval Medical Center, Portsmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine and saline in people with Post Dural Puncture Headache, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as measured by Visual Analog Scale (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.